Comparison of the effect of high versus low mean arterial pressure levels on clinical outcomes and complications in elderly patients during non-cardiothoracic surgery under general anesthesia: study protocol for a randomized controlled trial

Anmin Hu, Yan Qiu, Peng Zhang, Bailong Hu, Yali Yang, Shutao Li, Rui Zhao, Zhongjun Zhang, Yaoxian Zhang, Zihao Zheng, Chen Qiu, Furong Li, Xiaolei Gong, Anmin Hu, Yan Qiu, Peng Zhang, Bailong Hu, Yali Yang, Shutao Li, Rui Zhao, Zhongjun Zhang, Yaoxian Zhang, Zihao Zheng, Chen Qiu, Furong Li, Xiaolei Gong

Abstract

Background: Intraoperative blood pressure (BP) is a concern in daily clinic anesthesia and contributes to the differences in clinical outcome. We conducted a randomized controlled trial (RCT) to compare the effect of high vs. low mean arterial pressure (MAP) levels on clinical outcomes and complications in elderly patients under general anesthesia (GA).

Methods: In this multicenter, randomized, parallel-controlled, open-label, assessor-blinded clinical trial, 322 patients aged more than 65 years will be randomized for a low-level MAP (60-70 mmHg) or high-level MAP (90-100 mmHg) during non-cardiothoracic surgery under GA. The primary outcome will be the incidence of postoperative delirium. The secondary outcomes will include the delirium duration days, intraoperative urine volume, intraoperative blood loss, specific postoperative complications, and all-cause 28-day mortality.

Discussion: Results of this trial will help clarify whether BP management is beneficial for elderly patients under GA and will make clear whether the effect of high-level MAP can reduce the postoperative complication compared to low-level MAP.

Trial registration: ClinicalTrials.gov, NCT02857153 . Registered on 15 July 2016.

Keywords: Elderly patients; General anesthesia; Mean arterial pressure; Postoperative complication.

Conflict of interest statement

Consent for publication

Written informed consent was obtained from the patient for publication of their individual details and accompanying images in this manuscript. The consent form is held by the authors and is available for review by the Editor-in-Chief. The study’s findings will be published in peer-reviewed journals.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The schedule of enrollment, interventions, and assessments
Fig. 2
Fig. 2
Trial flow chart

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Source: PubMed

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